Purdue gets FDA priority review designation for hydrocodone bitartrate tablets

The once-daily, single-entity pain medication was formulated to include abuse-deterrent properties designed to make the product more difficult to manipulate for misuse or abuse by various routes of administration.

Purdue Pharma vice-president of regulatory affairs and chief medical officer Todd Baumgartner said it is imperative to provide healthcare professionals with an array of therapeutic options to ensure chronic pain patients receive individualised care.

"If approved by the FDA, this product will be a valuable therapy for treating chronic pain, and it is also designed to deter misuse and abuse by various routes of administration," Baumgartner said.

In April 2014, the company had submitted a new drug application (NDA) with the FDA seeking authorisation to market its hydrocodone bitartrate tablet, for which the FDA has set a target action date under the Prescription Drug User Fee Act of October 2014.

A series of manipulation and extraction studies and clinical abuse liability studies have been conducted by the company to evaluate the abuse-deterrent properties of the hydrocodone bitartrate extended-release tablets.

The company had presented the data from these clinical studies assessing the safety, efficacy, and abuse liability of this investigational medication at the 33rd Annual Scientific Meeting of the American Pain Society.